Treating Basal and Squamous Cell Carcinomas With Fractional Laser and Tirbanibulin Ointment

Phase 1

Recruiting

• Conditions: Keratinocyte Carcinoma; Squamous Cell Carcinoma; Basal Cell Carcinomas; Skin Cancer
• Interventions: Drug: Tirbanibulin ointment 1%; Device: non-ablative fractional laser

• Registration Number: NCT07010692
• Lead Sponsor: Bruce Robinson, MD

Brief Summary

The investigators seek to evaluate the effectiveness of fractional laser therapy and tirbanibulin ointment to treat squamous and basal cell carcinomas. This will be executed by using both thulium and erbium lasers on previously biopsy-confirmed SCCs and BCCs and applying bulk heating methods. Then, depending on the level of invasiveness, subjects may be instructed to apply the ointment over the course of five nights immediately following the treatment. The intention of this study is to minimize the need for invasive surgical procedures so as to optimize the cosmetic appearance, and provide a treatment option that is beneficial for a wide range of individuals.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-05-16
• Study First Submitted: 2025-05-30
• Study First Submitted QC: 2025-05-30
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-06
• Study First Posted: 2025-06-08
• Last Update Posted: 2025-06-11
• Primary Completion: 2030-05
• Study Completion: 2030-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

biopsy confirmed squamous and/or basal cell carcinoma not previously treated by another method.

Exclusion Criteria

• Cannot be pregnant at the time of treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Fractional Laser and Tirbanibulin Ointment	Tirbanibulin ointment 1%	Treatment of nodular or invasive carcinomas will be with fractional laser followed by a course of Klisyri ointment.
Fractional Laser Only	non-ablative fractional laser	Treatment of superficial or in situ carcinomas will be with fractional laser only.
Fractional Laser and Tirbanibulin Ointment	non-ablative fractional laser	Treatment of nodular or invasive carcinomas will be with fractional laser followed by a course of Klisyri ointment.

Primary Outcome Measures

Name	Time	Method
Clearance of skin cancer by evidence of no clinical and/or histological recurrence after 5 years.	From enrollment to the end of follow-up monitoring at 5 years.	Participants will be monitored at 1 month post-procedure then biannually thereafter for 5 years. Site with be observed for clinical recurrence. Optional biopsy at each visit.

Secondary Outcome Measures

Name	Time	Method
Recurrence rate/Appearance/Patient Satisfaction as compared to accepted alternatives (Surgical excision, Mohs, Electrodesiccation and curettage)	Ongoing review from enrollment to the end of 5 year follow-up period & also a final review at the end of 5 years for all participants.	Review the overall success of the treatment (recurrence and failure rates, appearance, patient satisfaction) compared to traditionally accepted alternative treatments including surgical excision, Mohs surgery, and Electrodesiccation and curettage

Trial Locations

Locations (1)

Bruce Robinson, MD; 🇺🇸 New York, New York, United States